000			02612nam a2200229Ia 4500
003			NULRC
005			20250520102818.0
008			250520s9999 xx 000 0 und d
020			_a9789241209786
040			_cNULRC
050			_aHV 5825 .W46 2013
245		0	_aWHO expert committee on biological standardization / _cWorld Health Organization
250			_aSixty-first report.
260			_aGeneva, Switzerland : _bWorld Health Organization, _cc2013
300			_axi, 384 pages ; _c24 cm.
365			_bUSD32.57
504			_aIncludes bibliographical references.
505			_a1. Introduction -- 2. General -- 3. International Recommendations, Guidelines and other matters related to the manufacture and quality control of biologicals -- 4. International reference materials-vaccines and related substances -- 5. International reference materials-blood products and related substances -- 6. International reference materials-diagnostic reagents -- 7. International reference materials-biotherapeutics (other than blood products) -- 8. International reference materials-antibiotics -- References -- Annex 1 to Annex 7/
520			_aThis report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations for the production and control of vaccines and other biologicals and the establishment of international biological reference materials. The report starts with a discussion of general issues brought to the attention of the Committee and provides information on the status and development of reference materials for various antibodies, antigens, blood products and related substances, cytokines, growth factors, endocrinological substances and in vitro diagnostic devices. The second part of the report, of particular relevance to manufacturers and national regulatory authorities, contains revised WHO recommendations for evaluation of animal-cell cultures as substrates for the manufacture of biological medicinal products, for production and control of hepatitis B vaccines and for production and control of yellow fever vaccines. New WHO guidelines on the independent lot release of vaccines are also included. Finally, there is an update to the procedure for the prequalification of vaccines. Also included are lists of recommendations, guidelines and other documents related to the manufacture and control of biological substances used in medicine, and of International Standards and Reference Reagents for biological substances.
650			_aBIOLOGICAL PRODUCTS -- STANDARDS
942			_2lcc _cBK
999			_c15916 _d15916